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New treatment option for Aortic Valve Stenosis
Official title Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis
ClinicalTrials.gov ID: NCT04613193
What this study is testing
- What it's testing
- The aim of this study is to investigate the effect of strict blood pressure control versus conventional care in patients with asymptomatic moderate to severe aortic valve stenosis. The study is a randomized (1:1), open label, controlled intervention trial.
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aortic valve peak velocity (Vmax) of 3.0-5.0 m/s and/or aortic valve area (AVA) ≤ 1.2 cm2
- Blood pressure: SBP \>= 127 mmHg measured by BP-TRU
- LVEF ≥ 50%
- Age \> 18 years
- Safe birth control management (intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal...
You likely can't join if
- Symptoms due to AS
- Symptomatic orthostatic hypotension and/or one minute standing SBP \< 110 mmHg (16).
- Suspicion of secondary hypertension
- Participation in other assigned by chance drug study (device studies accepted)
- Moderat to severe aortic valve regurgitation e.g. vena contracta \> 5 mm, assessed by echocardiography)
- Known or suspected ischemic heart disease (coronary angiography with \>70% stenosis in a major epicardial vessel, symptoms or signs of myocardial...
See the full eligibility criteria
- Aortic valve peak velocity (Vmax) of 3.0-5.0 m/s and/or aortic valve area (AVA) ≤ 1.2 cm2
- Blood pressure: SBP \>= 127 mmHg measured by BP-TRU
- LVEF ≥ 50%
- Age \> 18 years
- Safe birth control management (intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)) for women of...
- Negative urine-HCG for women of childbearing potential
- Ability to understand the written patient information and to give informed consent.
- Symptoms due to AS
- Symptomatic orthostatic hypotension and/or one minute standing SBP \< 110 mmHg (16).
- Suspicion of secondary hypertension
- Participation in other assigned by chance drug study (device studies accepted)
- Moderat to severe aortic valve regurgitation e.g. vena contracta \> 5 mm, assessed by echocardiography)
- Known or suspected ischemic heart disease (coronary angiography with \>70% stenosis in a major epicardial vessel, symptoms or signs of myocardial ischemia, e.g. angina pectoris, wall motion abnormalities). Patients who...
- Significant coronary obstructive lesions detected by baseline Cardiac CT that requires a revascularisation procedure.
- eGFR \< 30 ml/min or end-stage renal disease
- Other disease, comorbidity or treatment making the subject unsuitable for study participation as judged by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Herning, Denmark
- Horsens, Denmark
- Randers, Denmark
- Silkeborg, Denmark
- Viborg, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Herning, Denmark; Horsens, Denmark; Randers, Denmark; Silkeborg, Denmark; Viborg, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.